Events

Rappel de Softbank II 23.1.2.8 25.3.0.0

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Soft Computer Consultants, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    76046
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1097-2017
  • Date de mise en oeuvre de l'événement
    2016-10-06
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152048
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Software, transmission and storage, patient data - Product Code NSX
  • Cause
    Software error. potential for incorrect results.
  • Action
    Consignees were sent a recall notification, dated 10/06/2016, providing instructions for software correction. The firm indicates that the issue will be resolved with a mandatory hot fix. Hot fix will be released when its effectiveness is confirmed. Consignees are instructed to acknowledge receipt of the recall notification and grant permission for the recalling firm to load the hot fix when available. The firm can be contacted by calling Technical Support at 1-800-763-8522. Until the hot fix is available, consignees can still operate the software by exiting (Esc-Quit) the Test Verify option after each save changes (F12-Accept).

Device

Softbank II 23.1.2.8 25.3.0.0
  • Modèle / numéro de série
    Version: 23.1.2, 23.2.0, 25.0.0, 25.1.0, 25.2.0, 25.3.0
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide Distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WA, WI, WV, and the countries of Hawaii and Puerto Rico Canada & Jamaica
  • Description du dispositif
    SCC Soft Computer Softbank II software || Product Usage: || Supports single and multi-site transfusion services in healthcare facilities. Used by healthcare personal to document, query, and view the integrated information regarding patients and products. Quality control testing, test and transfusion history, transfusion management, inventory management, product distribution, and final disposition are all monitored using the software.
  • Manufacturer
    Soft Computer Consultants, Inc.

Manufacturer

Soft Computer Consultants, Inc.
  • Adresse du fabricant
    Soft Computer Consultants, Inc., 5400 Tech Data Dr, Clearwater FL 33760-3116
  • Société-mère du fabricant (2017)
    Soft Computer Consultants Inc.
  • Source
    USFDA